FDA.reportPublic FDA data

RHAPSIDO

Product NDC
0078-1483
11-digit product format
000781483
Labeler code
0078
Product ID
0078-1483_03fb4b82-836d-4847-a9b5-e5695da55c1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
remibrutinib
Dosage form
TABLET
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA218436
Marketing category
NDA
Marketing start
2025-09-30
Substance
REMIBRUTINIB
Active strength
25 mg/1
Pharmacologic classes
Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218436-001RHAPSIDOREMIBRUTINIB25MGTABLET / ORALRLD, RS2025-09-30

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218436-001104576472034-11-13U-42802025-10-21
N218436-00195120842034-11-13Drug substance, Drug product2025-10-21
N218436-001124198892043-01-19U-42812025-10-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218436-001NCE2030-09-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-30c2088c7a36db…
2026-09-14 22:38:342026-08N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-3084e616aacf4f…
2026-08-18 06:07:402026-07N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-3031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218436-001RHAPSIDO25MGTABLET / ORALRLD, RS2025-09-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N218436-001104576472034-11-13U-42802025-10-21c2088c7a36db…
2026-10-15 13:18:302026-09N218436-00195120842034-11-13Drug substance, Drug product2025-10-21c2088c7a36db…
2026-10-15 13:18:302026-09N218436-001124198892043-01-19U-42812025-10-21c2088c7a36db…
2026-09-14 22:38:342026-08N218436-001104576472034-11-13U-42802025-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N218436-00195120842034-11-13Drug substance, Drug product2025-10-2184e616aacf4f…
2026-09-14 22:38:342026-08N218436-001124198892043-01-19U-42812025-10-2184e616aacf4f…
2026-08-18 06:07:402026-07N218436-001104576472034-11-13U-42802025-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N218436-00195120842034-11-13Drug substance, Drug product2025-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N218436-001124198892043-01-19U-42812025-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218436-001104576472034-11-13U-42802025-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218436-00195120842034-11-13Drug substance, Drug product2025-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218436-001124198892043-01-20U-42812025-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218436-001104576472034-11-13U-42802025-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218436-00195120842034-11-13Drug substance, Drug product2025-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218436-001124198892043-01-20U-42812025-10-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218436-001104576472034-11-13U-42802025-10-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218436-00195120842034-11-13Drug substance, Drug product2025-10-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218436-001124198892043-01-19U-42812025-10-21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N218436-001NCE2030-09-30c2088c7a36db…
2026-09-14 22:38:342026-08N218436-001NCE2030-09-3084e616aacf4f…
2026-08-18 06:07:402026-07N218436-001NCE2030-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218436-001NCE2030-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218436-001NCE2030-09-3031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218436-001NCE2030-09-30a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
RHAPSIDO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
REMIBRUTINIB25 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1483-20RHAPSIDO60 in 1 BOTTLETABLET602
0078-1483-92RHAPSIDO30 in 1 BOTTLETABLET302
0078-1483-92RHAPSIDO2 in 1 CARTONTABLET22
0078-1483-93RHAPSIDO30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1483-20EA - Each0078-148316d7ab04-bb1c-43cb-95ee-50d7a266620a12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724392remibrutinib 25 MG Oral TabletPSNe5e89bff-6ced-4165-acc5-fb13136b3a3d2
2724398Rhapsido 25 MG Oral TabletPSNe5e89bff-6ced-4165-acc5-fb13136b3a3d2
2724398remibrutinib 25 MG Oral Tablet [Rhapsido]SBDe5e89bff-6ced-4165-acc5-fb13136b3a3d2
2724392remibrutinib 25 MG Oral TabletSCDe5e89bff-6ced-4165-acc5-fb13136b3a3d2
2724398Rhapsido 25 MG Oral TabletSYe5e89bff-6ced-4165-acc5-fb13136b3a3d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0078-1483-200007814832060 TABLET in 1 BOTTLE (0078-1483-20) 60 tablet2025-09-30NoNoCurrent
0078-1483-92000781483922 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE2 bottle2025-09-30YesNoCurrent
0078-1483-930007814839330 TABLET in 1 BOTTLE (0078-1483-93) 30 tablet2026-03-23YesNoCurrent